Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-12-04
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• Years 19-60

• No pathological symptoms or findings

• Suitable for the criteria for examination

• 90≤SBP≤139, 60≤DBP≤89

• Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2

• Contraceptive during the study period

• Volunteer for the study and sign to ICF

Exclusion Criteria:

• Subject with medical history which affect on the absorption of drug

• Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC< 500cells/mm3, ALC<500cells/mm3, Hb<8g/dL

• Subject with hypersensitivity reaction to HL-TOF and Xeljanz

• Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Subject who take a vaccination within 30 days

• Subject who take a medication such as barbiturates within 30 days

• Subject who take a medication that affect to the pharmacokinetics of drug within 10 days

• Subject who take alcohol more than 21 cups per week

• Subject who smoke 20 cigarettes per day

• Subject who participate in any clinical investigation within 6 month prior to study medication dosing

• Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days

• Subject with decision of non-participation through investigator's review